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Trial record 1 of 1 for:    COVGUT20
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NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients (COVGUT20)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04540406
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : September 5, 2021
Sponsor:
Collaborators:
University of South Florida
Rutgers University
Information provided by (Responsible Party):
Notitia Biotechnologies Company

Brief Summary:
This open-label, randomized, and controlled clinical trial aims to determine the feasibility and effectiveness of using NBT-NM108, a novel botanical-based fixed-combination drug, to modulate the gut microbiota and treat early-stage suspected or confirmed symptomatic COVID-19 patients.

Condition or disease Intervention/treatment Phase
Suspected or Confirmed COVID-19 Drug: NBT-NM108 Other: Usual Care Only Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modulation of Gut Microbiota With NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : January 1, 2022

Arm Intervention/treatment
Experimental: NBT-NM108 + Usual Care Drug: NBT-NM108
Taken in the form of drinks four times a day (before each main meal and 2 hours after dinner) for 28 days. Each drink is prepared by mixing one sachet (30 g) with 500 ml of water.

Active Comparator: Usual Care Only Other: Usual Care Only
Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.




Primary Outcome Measures :
  1. Gut Microbiota Composition [ Time Frame: Day 0 to 56 ]

Secondary Outcome Measures :
  1. Outcome of COVID-19 related illnesses [ Time Frame: At days 0, 14, 28, and 56 ]
    Discontinuation of home isolation status

  2. Outcome of COVID-19 related illnesses [ Time Frame: At days 0, 14, 28, and 56 ]
    Hospitalization status

  3. Outcome of COVID-19 related illnesses [ Time Frame: At days 0, 14, 28, and 56 ]
    Deaths

  4. Proportion of participants who are "alive and not admitted to the hospital" [ Time Frame: At days 0, 14, 28, and 56 ]
  5. Proportion of participants who visit the emergency room [ Time Frame: At days 0, 14, 28, and 56 ]
  6. Proportion of participants who have complete resolution of all objective symptoms [ Time Frame: At days 0, 14, 28, and 56 ]
    All vital signs are within the normal range for at least 24 h, including body temperature 36.5-37.5°C (97.7-99.5°F), pulse rate <90/min, respiratory rate 12-16/min and oxygen saturation level at 95-100%

  7. Proportion of participants who have complete resolution of subjective symptoms [ Time Frame: At days 0, 14, 28, and 56 ]
    Absence of all COVID-19-like symptoms listed by CDC (updated May 13, 2020) for at least 24 h, including fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting and diarrhea

  8. Illness severity based on the categorization from FDA COVID-19 Guidance Document [ Time Frame: At days 0, 14, 28, and 56 ]
  9. Illness severity based the Ordinal Scale for Clinical Improvement from the World Health Organization [ Time Frame: At days 0, 14, 28, and 56 ]
  10. Body temperature (F) [ Time Frame: At days 0, 14, 28, and 56 ]
  11. Oxygen saturation SpO2 level [ Time Frame: At days 0, 14, 28, and 56 ]
  12. Pulse rate per minute [ Time Frame: At days 0, 14, 28, and 56 ]
  13. Respiratory rate per minute [ Time Frame: At days 0, 14, 28, and 56 ]
  14. Fasting blood glucose (mg/dl) [ Time Frame: At days 0, 14, 28, and 56 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 18 to 79 (inclusive)
  • Have mild to moderate COVID-19-like symptoms based on the symptom list from CDC (updated May 13, 2020) and the severity categorization from FDA [18]:

    a) Mild COVID-19

  • Fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea
  • No clinical signs indicative of moderate, severe, or critical illness severity

    b) Moderate COVID-19

  • Symptoms of moderate illness with COVID-19 could include any symptom of mild illness or shortness of breath with exertion
  • Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths/min, oxygen saturation level > 93% on room air at sea level, heart rate ≥ 90 beats/min
  • No clinical signs indicative of severe or critical illness severity
  • Directed to home isolation by study physician
  • Confirm study enrollment within 7 days of symptom onset
  • Practice acceptable contraception, i.e., continue with current methods if participants are already practicing contraception, otherwise participants must agree to practicing contraception with a barrier method (male or female condom) or abstinence, from Day 1 to Day 35 or 7 days after the last dose of NBT-NM108 if they do not complete the 28-day intervention.
  • Have access to a smartphone, tablet, computer, or other qualifying internet-enabled device and daily internet access
  • Understand and be able to follow written and oral instructions in English
  • Provide informed consent

Exclusion Criteria

  • Have tested positive for COVID-19 and recovered
  • Receiving vancomycin monotherapy or oral broad-spectrum antibiotics
  • Inability to receive oral fluids
  • Self-reported allergy or intolerance to any ingredients in NBT-NM108
  • Surgery involving the intestinal lumen within the last 30 days
  • Documented diagnosis of celiac disease, inflammatory bowel disease or irritable bowel syndrome
  • Pregnancy or breastfeeding
  • Bariatric surgery
  • Immunocompromised, e.g., cancer treatment, bone marrow/organ transplant, immune deficiency, poorly controlled HIV/AIDS, prolonged use of steroids or other immunosuppressant medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540406


Contacts
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Contact: Elsa Wang 844-874-2520 covgut20@sebs.rutgers.edu

Locations
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United States, Florida
University of South Florida Morsani College of Medicine Recruiting
Tampa, Florida, United States, 33612
Contact: Asa Oxner, MD    813-974-1440    aoxner@usf.edu   
Sponsors and Collaborators
Notitia Biotechnologies Company
University of South Florida
Rutgers University
Investigators
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Principal Investigator: Asa Oxner, MD University of South Florida
Principal Investigator: Liping Zhao, PhD Rutgers University
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Responsible Party: Notitia Biotechnologies Company
ClinicalTrials.gov Identifier: NCT04540406    
Other Study ID Numbers: NBTNM10810012020
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Notitia Biotechnologies Company:
COVID-19
NBT-NM108
Notitia Biotechnologies Company
Notitia Biotechnologies
Microbiome
Microbiota
Gut microbiome
Gut microbiota
Corona Virus
Novel Corona Virus
SARS-CoV-2